DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS


Device Classification Name

ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl

510(k) Number K072395
Device Name DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
Applicant
DIAZYME LABORATORIES
12889 gregg court
poway, 
CA 
92064

Applicant Contact charles yu
Correspondent
DIAZYME LABORATORIES
12889 gregg court
poway, 
CA 
92064

Correspodent Contact charles yu
Regulation Number 862.1475
Classification Product Code
LBS  
Subsequent Product Code
JJX  
Date Received 08/27/2007
Decision Date 01/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No